Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

US FDA Advisory Committees As The Court Of Appeals

Executive Summary

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.

You may also be interested in...



Ardelyx’s Tenapanor: FDA Panel To Weigh Treatment Effect Size In Context Of Approved Agents

Agency previously declined to approved tenapanor for the control of serum phosphorous levels in chronic kidney disease patients on dialysis, saying the magnitude of treatment effect on a surrogate endpoint in three clinical trials was less than that observed with approved drugs and of unclear significance.

House GOP Targets US FDA Applications With China-Only Data, Cites General Oversight Concerns

While industry concern with FDA’s policy shift on clinical data from China has focused on the disruption in business plans, Republican lawmakers appear to feel that the agency has not gone far enough and are seeking a GAO review of FDA’s entire bioresearch monitoring program.

House User Fee Mark-Up: Few Tweaks, But Concerns About ALS And Accelerated Approval

Clinical trial diversity, FDA hiring authority, and inactive ingredient disclosure provisions all get slight modifications. The bill glides through committee, but not without some complaints about agency performance.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS146152

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel